|BrainStorm's Clinical Trial is Fast-Tracked to Phase IIa; CEL-SCI Expands Its Phase III Head and Neck Cancer Trial|
|By Staff and Wire Reports|
|Thursday, 17 July 2014 18:20|
BrainStorm Cell Therapeutics (OTC.QB: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today that the Israeli Ministry of Health has fast-tracked its current Phase I/II ALS safety trial to a Phase IIa dose-escalating trial, significantly expediting the company’s clinical development program and saving valuable time. The trial, which will evaluate the safety and preliminary efficacy of BrainStorm’s NurOwn stem cell therapy candidate, will be launched immediately at the Hadassah Medical Center in Jerusalem.
The Ministry of Health approved acceleration to a Phase IIa trial based on evaluation of only 12 of the initial cohort of 24 patients in the company’s Phase I/II trial at Hadassah. In the Phase IIa trial, the second group of 12 patients will receive combined intramuscular and intrathecal administration of NurOwn cells in three cohorts, with increasing doses. The study participants, who have already been recruited, will be followed for three to six months after transplantation.
“Acceleration to Phase IIa will save us critical time, enabling us to proceed much more quickly with achieving our goal of developing an effective treatment for ALS,” commented Dr. Adrian Harel, BrainStorm’s CEO.
Professor Dimitrios Karussis, Principal Investigator of BrainStorm’s Phase I/II trial at Hadassah, commented: “Based on the positive results we have seen for the first 12 patients, we are eager to begin the next stage of clinical testing, and are delighted that the Ministry of Health has given us the green light to proceed to Phase IIa.”
BrainStorm has been conducting a Phase I/II clinical trial in ALS patients at the Hadassah Medical Center in Jerusalem since June 2011, and plans to launch the Phase IIa study immediately. The company is also planning to expand its clinical development to the United States in 2013, pending FDA approval. Towards that goal, the Company has entered into a Memorandum of Understanding with the University of Massachusetts Medical School and Massachusetts General Hospital to begin ALS human clinical trials at these institutions.
CEL-SCI Corporation (NYSE MKT: CVM) announced Sri Lanka’s Ministry of Health has cleared the Company to commence patient enrollment for its Phase III Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Injection) in Sri Lanka. This follows similar clearance to conduct the Phase III study in the UK and Austria during the past weeks. Further expansion of the trial is underway with a goal to have a total of 880 patients enrolled through about 100 clinical centers in 20 countries by the end of 2015.
CEL-SCI’s global pivotal Phase III clinical trial is the largest trial for head and neck cancer in the world. The trial, which already has over 220 patients enrolled, is assessing the Company’s investigational immunotherapeutic agent Multikine as a potential first-line treatment for advanced primary head and neck cancer. If approved for use following completion of CEL-SCI's clinical development program for head and neck cancer, Multikine would be a different type of therapy in the fight against cancer; one that appears to have the potential to work with the body's natural immune system in the fight against tumors.
“If Multikine can be proven to harness the immune system against cancer, we believe this could offer a new modality for the treatment of head and neck cancer that could work in concert with the other methods – surgery, chemotherapy, and radiation therapy, used today for the treatment of this debilitating disease.” stated CEL-SCI Chief Executive Officer Geert Kersten.
About Multikine Phase III Study -- The Multikine Phase III study is enrolling patients with advanced primary, not yet treated, head and neck cancer. The objective of the study is to demonstrate a statistically significant improvement in overall survival of enrolled patients who are treated with the Multikine treatment regimen plus Standard of Care (SOC) vs. subjects who are treated with SOC only.
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